Strategic Medical Affairs in 2019
Written by Dr Niamh O’Reilly

Healthcare systems globally are facing numerous challenges. Among these is managing the health of ageing populations and a growing number of people with chronic lifestyle related diseases, which are placing increasing pressure on healthcare budgets. As 2019 fast approaches, it is timely to reflect on the evolving role of medical affairs as a strategic function in an increasingly complex healthcare landscape.

Changing healthcare landscape

Some key challenges facing healthcare stakeholders include responding to complex changes in health policy and regulations, engaging consumers and improving the patient experience, as well as implementing more outcomes focused value-based healthcare models (1, 2). Precision medicines represent a new era of therapies that have emerged in recent years as a result of innovative medical research and are challenging the status quo of the healthcare landscape. These therapies require patients to undergo testing with a companion diagnostic to enable selection of those patients who will benefit the most from treatment (3). This maximises the value of medicines by way of delivering improved health outcomes and/or quality of life for a cohort expected to positively respond, while it may also lead to reduced healthcare costs whereby ineffective treatments and other interventions are avoided.

Australians have also indicated their readiness to embrace elements of the modern healthcare landscape with 75% of people in a recent poll claiming they are willing to use genetic testing to identify the most effective drug for their treatment needs, while 95% would share their test results to improve treatments for future patients (4). From a pharmaceutical industry perspective, it is suggested that industry has a presence on the Medical Services Advisory Committee (MSAC), which is the body responsible for appraising new companion diagnostics, as well as novel cell-based therapies such as CAR-T cell therapy (5). Such a move could enable improved feedback to companies from the Committee that would help to inform strategic medical affairs plans.

Communicating therapy value

The medical affairs function is recognised as increasingly important in bridging the clinical and commercial interests of pharmaceutical and medical device companies to enable effective communication of the value of their products with a variety of stakeholders. To achieve this, medical affairs teams are increasingly drawing on not only clinical and cost effectiveness data, but also real-world evidence (RWE) or patient-outcomes data gathered outside of randomised controlled trials (2).

With a growing focus on implementing outcomes-based healthcare models, companies are placing emphasis on understanding the patient journey and seeking to add value at various touch points along this journey with their therapies. In addition, they are also focused on providing tailored support such as various digital tools in aiming to ease the burden of disease management. RWE can help provide a more holistic view of the patient journey and highlight the benefits of a treatment regime (therapy and any additional supports), as well as assist in communicating therapy value to relevant stakeholders.

The New Year is promising an influx of therapies awaiting regulatory approval from the TGA (6). However, securing registration approval is only the beginning for companies seeking to commercialise healthcare products in Australia. Forward thinking healthcare companies increasingly understand the necessity to invest in implementing a well-planned medical affairs strategy to help maximise therapy value in contributing to the achievement of commercial goals.

CRC’s experienced Medical Affairs team has the expertise to provide tailored strategic solutions across the entire product development life cycle that extract maximum value for our clients’ product portfolios in contributing to commercial success.

CRC provides Medical Affairs solutions to the Pharmaceutical industry throughout the Drug Development Life Cycle. Our objective is to maximise the value of therapeutic compounds from pre-launch through to commercialisation and beyond.